Associate Director, QA

Becton Dickinson Medical Devices•San Diego, CA

14h•Onsite

About The Position

The Associate Director of Quality Assurance reports to the Sr. Director of Quality, BD Life Science (BDB) Business Unit. This position is responsible for the Quality Assurance and provides direct management to technical and managerial staff often at multiple locations. The role significantly influences the definition of the global strategy and determines the tactics required to achieve objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; the Associate Director ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. This position will also support the planning and implementation of Reagent Quality strategy for BDB aligned with corporate key driver goals. Success is measured in terms of the frequency and scale of product quality and organizational issues as well as business process effectiveness. Through internal and external stakeholder engagement; and people development; the Associate Director produces durable and industry leading results supporting key business drivers. Engage with (or may lead) global quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Ensure the functional quality organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures.

Requirements

A minimum of a bachelor’s degree in science, engineering, or other relevant discipline with a minimum of eight (8) years relevant experience in the pharmaceutical and/or medical device industries, with three (3) years supervisory experience.
Experience with GMP/ISO compliance and documentation, and FDA Regulations.
Knowledge of manufacturing systems, medical products and related materials, quality testing and quality auditing.

Nice To Haves

Six Sigma or Lean certification desired.

Responsibilities

Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
Support Corporate initiatives, Key Driver Goals (KDGs) and Biosciences objectives to improve reagent plant product quality.
Ensure programs are led, supervised, and delivered according to corporate and Biosciences timeline.
Continuously evaluate progress toward objectives adapting them to meet customer and business needs.
Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives.
Significantly contribute to development of local and/or global strategies.
Ensure the functional quality organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures.
Mentor and develop personnel, including dedicated succession planning and contingency management.
Support new product development for operational aspects and ensure adequate design transfer from R&D.
Serves on Leadership Teams such as Platform, ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LT.
Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on effective solution solutions.
Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.
Perceived as leader with vision possessing subject matter expert knowledge of global regulations.
May have P&L accountability.
Act as management representative for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
Build an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
Perform all other duties and supports projects as assigned.

Benefits

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health.
At BD, you’ll discover a culture in which you can learn, grow, and thrive.
Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.
We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Our salary or hourly rate ranges reward associates fairly and competitively.
We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully.
The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location.
Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.